Actively Recruiting
Pilot Study of Biodegradable Stents in Primary Sclerosing Cholangitis - BSTPSC
Led by King's College Hospital NHS Trust · Updated on 2026-05-29
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of biodegradable stents in patients with Primary Sclerosing Cholangitis (PSC) who have high grade strictures. The study aims to see if these stents can improve bile flow by remodeling the strictures while requiring fewer interventions compared to balloon dilation alone. This pilot study focuses on the technical success and safety of placing biodegradable stents during endoscopic retrograde cholangiopancreatography (ERC). Participants will receive an Archimedes biodegradable stent inserted at the time of ERC to treat their high grade strictures. The study will monitor patients for up to 12 months to assess the recurrence-free rate of strictures, changes in symptoms using the Amsterdam cholestatic complaints score, improvements in liver function tests, and quality of life as measured by the Short Form-36 questionnaire. The trial will also track mortality, morbidity, complications, liver disease progression, and the need for liver transplantation. During the study, participants will undergo assessments at 2 weeks, 12 weeks, and 12 months after the initial stent placement. These evaluations include symptom scores, liver function tests, and quality of life measures. Researchers will also monitor for adverse events related to ERC and stent placement, stricture recurrence, development of ascites, and any liver transplant requirements. The total follow-up period for each participant is 12 months to capture both short- and longer-term outcomes.
CONDITIONS
Brief Title
Biodegradable Stents in Primary Sclerosing Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Primary Sclerosing Cholangitis (PSC) and has a high grade stricture
You will not qualify if you...
- Prior stenting or balloon dilatation within the previous 4 months
- Signs of bacterial cholangitis defined by definite cholangitis
- Change of UDCA therapy within 4 weeks
- Inability to give informed consent
- Biliary cirrhosis with Child Pugh score greater than 8
- Estimated transplant free survival less than 2 years as calculated by Mayo score greater than 2
- Suspicion of cholangiocarcinoma based on imaging, MRCP with mass lesion, or high CA19.9 levels
- Signs of current malignancy other than basal cell carcinoma
- Life expectancy less than 24 months
- Women pregnant at time of screening
- HIV or acute or chronic hepatitis B or hepatitis C or substance misuse within previous 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of ERCP procedure
Participants receive the insertion of a biodegradable Archimedes stent at ERCP to treat high grade strictures associated with Primary Sclerosing Cholangitis.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for clinical outcomes including liver function, symptom changes, quality of life, and recurrence of strictures over 12 months after stent placement.
Visits at 2 weeks, 12 weeks, and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
King's College Hospital, London
London, United Kingdom, SE5 9RS
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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